Many medical devices have components such as needleless access ports and connection ports in different locations for liquid injection, liquid sampling, or liquid drainage. These needleless access ports generally have rubber valves or stoppers that prevent liquid from leaking, and also allow needleless syringes to access the port for liquid injection or liquid sample collection. These devices include but are not limited to infusion bags or systems, intravenous (IV) catheters, chest tubes, drainage tubes, connection ports including luer locks, ear tubes, urine bags, or urine collection systems. The embodiments of the invention described below are intended for use with these and any other appropriate devices. Contamination at these liquid access ports and luer locks is a major cause of healthcare-associated infection (HAI). HAI causes a number of deaths and creates a huge cost for healthcare. One of the major reasons for infection is incomplete or unacceptable disinfection during the liquid injection process. Many have attempted to reduce the chances of HAI by making the antiseptic procedure easy and simple to reduce the potential for human error. For example, U.S. Publication No. 2007/0112333 describes a patient fluid line access valve antimicrobial cap and cleaner. This cap contains a dry pad impregnated with antimicrobial agent. This solid non-porous cap covers the access portion when the port is not in use. Other examples of needleless access ports are shown and described in U.S. Patent Application Publication No. 2009/0008393, which describes a pair of nestable caps; U.S. Pat. No. 7,114,701, which describes needleless access port valves with a venting hole; U.S. Pat. No. 7,981,090, which describes luer activated devices with antimicrobial agents; and U.S. Pat. No. 7,780,794, which describes medical cleaning devices that include a non-porous cap and compressible cleaning materials. This cap can be used to clean the site with an embedded cleaning agent. However, improvements to needless access port caps are still needed in order to reduce infections and for ease of use.
Many medical devices that handle liquid need to be vented in order to allow stable and good liquid flow. Two common devices that handle liquid are infusion bags and urine bags. Infusion bags are used to hold liquids to be delivered into the body, such as an intravenous (IV) bag, a chemotherapy bag, or any other liquid substance to be delivered to a patient. The bag needs to be vented in order to help balance the pressure. Urine bags need vents in order to allow urine flow into the reservoir. Tubing and luer locks also need vents. Tubing and luer locks are common locations for trapping air bubbles. Air bubbles trapped in the IV kits are potentially dangerous because air bubbles delivered into the vascular system can pose serious health risks.
Many of these medical devices have venting systems, but they are not always optimal. For example, some urine bags have a vent in the bag, and infusion bags have a vent on one end of the bag. The vents help balance the pressure inside and outside the bag and reduce liquid flow resistance. However, many of these vents in the bags are not satisfactory. In some instances, they are located too far away from where they are needed in order to affect liquid flow in narrow tubing. They also do not help in removing the trapped air bubbles in the tubing or luers. Some of the currently available infusion bags or containers need vents, and in many developing countries, the nurses have to punch a needle into the infusion bag to provide venting. However, this practice increases the chance of contamination from the air. Additionally, even for bags that do not require a vent, a vent would provide better liquid flow.
There have been a number of attempts to improve needleless access ports and needleless connectors. U.S. Patent Application Publication 2010/0036330 describes a needleless connector intended to prevent retro flow using a vent in a housing. U.S. Pat. No. 5,065,783 describes a valve with a self-sealing cannula using a rubber material. U.S. Patent Application Publication No. 2012/0130305 describes an apparatus with a membrane vent. However, all these materials used for vents and methods of venting disclosed in the prior art are different from those described herein. There also have been a number of methods for disinfecting medical devices. U.S. Patent Application Publication No. 2009/008393 describes an antiseptic cap design for a catheter. U.S. Patent Application Publication No. 2008/0132880 discloses catheter cleaning devices. U.S. Publication 2008/0085680 describes a needless hub disinfection device/cap. U.S. Patent Application Publication No. 2008/0038167 discloses a disinfection cap. U.S. Patent Application Publication No. 2008/0027399 describes a valve cleaning device. U.S. Patent Application Publication No. 2007/0202177 describes antimicrobial compositions and methods for locking catheters. All of these methods are not satisfactory.
Improvements to medical device access ports, including methods for maintaining cleanliness, for disinfecting and for venting are needed.